Sigma Medical Supplies Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sigma Medical Supplies Corp.” (first 2011, latest 2021), across 1 product code in 1 review panel. Median 510(k) review time under this name: 239 days. Since 2017 the median was 84 days, against 226 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 448 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 84 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 239 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sigma Medical Supplies Corp. took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 226 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRG | Wrap, Sterilization | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Sigma Medical Supplies Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202462 | SIGMA Sterilization Pouch and Roll | FRG | 2021-04-23 | 239 |
| K180672 | Sterilization Pouch/Roll Made with Tyvek | FRG | 2018-06-06 | 84 |
| K180661 | SIGMA Sterilization Pouch and Roll | FRG | 2018-06-05 | 83 |
| K133838 | STERILIZATION POUCH/ROLL MADE WITH TYVEK | FRG | 2015-03-11 | 448 |
| K102158 | SIGMA STERILIZATION POUCH & ROLL | FRG | 2011-08-02 | 368 |
Recalls
openFDA lists no recalls under a recalling firm named Sigma Medical Supplies Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sigma Chemical Co. (231 510(k)s)
- Sigma Diagnostics, Inc. (164 510(k)s)
- Sigma Medical, Inc. (13 510(k)s)
- Sigma (6 510(k)s)
- Sigma Intl. (3 510(k)s)
- Sigma Cell Culture Reagents (2 510(k)s)
- Sigma Biomedical (1 510(k)s)
- Sigma Biomedics, Inc. (1 510(k)s)
- Sigma Distribution & Supply, Inc. (1 510(k)s)
- Sigma Intl. General Medical Apparatus, Inc. (1 510(k)s)
- Sigma Scientific Services, LLC (1 510(k)s)
- Sigma Teleproducts, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sigma Medical Supplies Corp.?
FDA lists 5 510(k) clearances under the applicant name “Sigma Medical Supplies Corp.” (first 2011, latest 2021), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sigma Medical Supplies Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sigma Medical Supplies Corp. is 239 days. Since 2017: 84 days, versus 226 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sigma Medical Supplies Corp.?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 5).
Next steps
- See all 5 Sigma Medical Supplies Corp. clearances with predicates and recalls
- Run predicate analysis for product code FRG, Sigma Medical Supplies Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.